Shares of Zai Lab (09688) have risen against the broader market trend, gaining over 7%. At the time of writing, the stock was up 6.27% to HK$14.4, with a trading volume of HK$72.5449 million.
Catalyst for the Move
The company recently announced that the European Medicines Agency has granted orphan drug designation to zocilurtatug pelitecan, known as zoci (formerly ZL-1310). This is a first-in-class antibody-drug conjugate targeting Delta-like ligand 3 (DLL3), intended for the treatment of neuroendocrine carcinoma of pulmonary origin.
This follows prior designations from the U.S. Food and Drug Administration, which had already granted zoci both Fast Track Designation and orphan drug status for treating small cell lung cancer. The FDA recently also awarded Fast Track Designation for zoci's use in treating extrapulmonary neuroendocrine carcinoma.
Product Profile and Potential
Zoci is a novel ADC targeting DLL3, a validated therapeutic target that is overexpressed in various neuroendocrine tumors, including SCLC and extrapulmonary NECs. This overexpression is often linked to poor clinical outcomes. Zoci has the potential to become Zai Lab's first globally commercialized oncology product. The company plans to initiate three registrational studies by the end of 2026, covering second-line and later SCLC, first-line SCLC, and extrapulmonary neuroendocrine carcinoma.
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